Magellan(TM) Robotic System to Be Featured in Live Case at Transcatheter Cardiovascular Therapeutics (TCT) Conference
MOUNTAIN VIEW, CA, Oct 28, 2013 (Marketwired via COMTEX) --
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in
intravascular robotics, today announced that Dr. Barry Katzen,
founder and Medical Director of Baptist Cardiac & Vascular Institute
(Baptist Hospital of Miami), is scheduled to utilize the Magellan(TM)
Robotic System in a live endovascular aneurysm repair (EVAR) case at
the Transcatheter Cardiovascular Therapeutics (TCT) conference in the
Main Arena II at the Moscone Center in San Francisco, California on
Wednesday, October 30th at 2:30 PM ET.
"Robotics offer the ability to achieve controlled catheter delivery
and the delivery of a device that is generally significantly more
precise and stable than a conventional sheath for purposes of
treatment," stated Dr. Katzen. "The use of robotics in endovascular
procedures has the potential to make procedures safer, more effective
and reduce the time procedures take to complete, which would benefit
patients, physicians and hospitals."
"We are excited to, once again, have Dr. Katzen showcasing our
technology at TCT, which is the world's largest educational meeting
focused on interventional vascular procedures," said Bruce Barclay,
president and CEO of Hansen Medical. "We continue to build a growing
body of positive clinical data with the Magellan system, and live
cases such as this most recent procedure by Dr. Katzen provide Hansen
Medical with the opportunity to highlight to the interventional
vascular community how the Magellan system can significantly enhance
About the Magellan(TM) Robotic System
Hansen Medical's Magellan
Robotic System is intended to be used to facilitate navigation to
anatomical targets in the peripheral vasculature and subsequently
provide a conduit for manual placement of therapeutic devices. The
Magellan System is designed to deliver predictability to simple and
complex endovascular procedures. Since its commercial introduction in
the U.S. and Europe, the Magellan System has demonstrated its
clinical versatility in many cases in a broad variety of peripheral
vascular procedure types in centers across the US and Europe. The
system is based upon the flexible robotic technology incorporated in
the Sensei-X(R) Robotic Catheter System currently sold in the U.S.
and Europe, which has been used in more than 10,000 patients, but
includes a number of key enhancements. In particular, the Magellan
-- Provides solid catheter stability for placement of therapeutic
-- Is designed to enable predictable procedure times and increased case
-- Allows for independent, individual robotic control of the distal tips
of both the outer sheath and the inner leader catheter, as well as
robotic manipulation of standard guidewires.
-- Is designed to allow for sufficient extension inside the body to
access hard to reach peripheral anatomy.
-- Preserves the open architecture featured in the Sensei System to allow
for the subsequent use of many 6F therapeutic devices on the market
-- Is designed to potentially reduce physician radiation exposure and
fatigue by employing a remote physician workstation.
About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain
View, California, is a global leader in intravascular robotics,
developing products and technology designed to enable the accurate
positioning, manipulation and control of catheters and catheter-based
technologies. The Company's Magellan(TM) Robotic System, 9Fr
Magellan(TM) Robotic Catheter and related accessories, which are
intended to facilitate navigation to anatomical targets in the
peripheral vasculature and subsequently provide a conduit for manual
placement of therapeutic devices, have undergone both CE marking and
510(k) clearance and are commercially available in the European
Union, and the U.S. In the European Union, the Company's Sensei(R) X
Robotic Catheter System and Artisan(R) and Artisan Extend(R) Control
Catheters are cleared for use during electrophysiology (EP)
procedures, such as guiding catheters in the treatment of atrial
fibrillation (AF), and the Lynx(R) Robotic Ablation Catheter is
cleared for the treatment of AF. This robotic catheter system is
compatible with fluoroscopy, ultrasound, 3D surface map and patient
electrocardiogram data. In the U.S., the Company's Sensei X Robotic
Catheter System and Artisan and Artisan Extend Control Catheters are
cleared by the U.S. Food and Drug Administration for manipulation and
control of certain mapping catheters in EP procedures. In the U.S.,
the Sensei X Robotic Catheter System is not approved for use in
guiding ablation procedures; this use remains experimental. The U.S.
product labeling therefore provides that the safety and effectiveness
of the Sensei X Robotic Catheter System and Artisan and Artisan
Extend Control Catheter for use with cardiac ablation catheters in
the treatment of cardiac arrhythmias, including AF, have not been
established. Additional information can be found at
This press release contains
forward-looking statements regarding, among other things, statements
relating to goals, plans, objectives, milestones and future events.
All statements, other than statements of historical fact, are
statements that could be deemed forward-looking statements, including
statements containing the words "plan," "expects," "potential,"
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These statements are based on the current estimates and assumptions
of our management as of the date of this press release and are
subject to risks, uncertainties, changes in circumstances and other
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regulatory, manufacturing, sales and customer service challenges in
developing new products and entering new markets; potential safety
and regulatory issues that could slow or suspend our sales; the
effect of credit, financial and economic conditions on capital
spending by our potential customers; the uncertain timelines for the
sales cycle for newly introduced products; the rate of adoption of
our systems and the rate of use of our catheters; the scope and
validity of intellectual property rights applicable to our products;
competition from other companies; our ability to recruit and retain
key personnel; our ability to maintain our remedial actions over
previously reported material weaknesses in internal controls over
financial reporting; our ability to manage expenses and cash flow,
and obtain additional financing; and other risks more fully described
in the "Risk Factors" section of our Quarterly Report on Form 10-Q
for the quarter ended June 30, 2013 filed with the SEC on August 9,
2013 and the risks discussed in our other reports filed with the SEC.
Given these uncertainties, you should not place undue reliance on the
forward-looking statements in this press release. We undertake no
obligation to revise or update information herein to reflect events
or circumstances in the future, even if new information becomes
Hansen Medical, Heart Design (Logo), Hansen Medical (with Heart
Design), Sensei and Lynx are registered trademarks, and Magellan and
NorthStar are trademarks of Hansen Medical, Inc. in the United States
and other countries.
Peter J. Mariani
Chief Financial Officer
Hansen Medical, Inc.
FTI Consulting, Inc.
SOURCE: Hansen Medical, Inc.
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